Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:

To assess the pharmacokinetics of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of area under the curve and Cmax in cancer patients treated with emetogenic chemotherapy. [ Time Frame: Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the efficacy of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of number of episodes of nausea and vomiting in cancer patients treated with emetogenic chemotherapy. [ Time Frame: 1 week (post-chemotherapy) ] [ Designated as safety issue: No ]

5-Hydroxitryptamine3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous palonosetron.Patients receiving platinum-based chemotherapy will be randomized to receive palonosetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of subcutaneous and IV palonosetron will be prospectively compared.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01046240

Locations

Spain

Clinica Universidad de Navarra

Pamplona, Navarra, Spain, 31008

Sponsors and Collaborators

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

Principal Investigator:

Belen Sadaba, MD, PhD

Clinica Universidad de Navarra

More Information

No publications provided by Clinica Universidad de Navarra, Universidad de Navarra